On October 4, 2016, Nurse Assist announced a voluntary recall of all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia (also called B. cepacia) bloodstream infections with the product. According to the CDC, the effects on people of B. cepacia, a group of bacteria that can be found in soil and water and are often resistant to common antibiotics, “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.”
Nurse Assist became aware of some patients developing B. cepacia bloodstream infections while receiving intravenous care using prepackaged saline flushes from Nurse Assist. The lots being recalled were distributed to customers and distributors between February 2, 2016, and September 30, 2016.
Recalled lots included four product numbers. Product Numbers 1203, 1205, and 1210 are packaged 30 syringes to an inner carton and six inner cartons in a case (180 syringes). For product number 1210-BP, 100 syringes are packaged in an inner carton with four inner cartons in a case (400 syringes). Lot code information can be found on the outer case panel, the back panel of the inner carton, and on each syringe label.
See the FDA Safety Alert
Also see the Recall
See also Medical Law Perspectives, June 2016 Report: How Risky Is Going to the Hospital? The Dangers and Liabilities of Healthcare-Associated Infections
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication